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University of Wisconsin–Madison

HRPP Newsletter April 2022

Updated IRBs Compliance Statement

Study sponsors often request IRB rosters for compliance documentation purposes. For confidentiality reasons, the UW-Madison IRBs don’t publish their rosters. However, an updated compliance statement is available on the new IRB website via a link on the About Us page that describes the composition of the committees, the UW-Madison FWA, and the regulations that govern the IRBs. The compliance statement can be provided to sponsors, when requested.

Reliance and Navigation Team (RELIANT) Updates

New Questions in Cede Application:

To ensure compliance with requirements for depositing genetic data in NIH’s dbGAP, new questions have been added to the cede application. The questions ask whether genetic testing will be conducted and if so, whether genetic data will be deposited into dbGAP. While NIH funded studies must submit genetic data to dbGAP, such data can be deposited regardless of funding source. To determine whether data will be deposited in dbGAP, you may need to consult with the study sponsor, coordinating center, and/or PI.

Tips for Cede Applications to Other External IRBs (University, Health Care System):

  • Before submitting a cede application, confirm whether the UW is engaged in human subjects research. If your role in a study is limited to activities such as data analysis, consulting on study design, or manuscript preparation, a cede application may not be required for your role in that study. Please see HRP 311 Engagement Determination for guidance.
  • Single IRB review is not required for exempt studies and the UW will not cede IRB review for exempt projects.
  • Do not submit a cede application until you have confirmation that the lead study team has begun the process of adding the UW to the study.
  • If subjects will be enrolled at the UW, be sure to use the consent template approved by the reviewing IRB and refer to HRP 502 Institutional Consent Language when drafting the UW version of the consent document.

New PREP Course: Introduction to Survey Best Practices

Register here for "Introduction to Survey Best Practices" on Thursday, 5/19 from 10:00-11:30 am (CT). Dr. Jennifer Dykema, Faculty Director of the UW Survey Center, will share a brief introduction to best practices in designing questions and questionnaires for surveys. Some basic tips and resources for developing and administering questionnaires will be shared. Some common pitfalls (and how to avoid them) and frequently asked questions will be addressed.

Principal Investigator and Study Team Responsibilities When Leaving UW-Madison

IRB-related responsibilities

If a study team member (including the PI) is leaving UW-Madison, the IRB application needs to be updated to reflect this. If the PI leaves UW-Madison while the study is ongoing and does not intend to find another PI to assume PI responsibilities, they should contact the IRB office to discuss transfer or closure of the study prior to departure.  Please note that we strongly recommend allowing extra time prior to your departure to allow for any processes associated with transfer or study closure to be completed before UW-Madison credentials are terminated.  If a study team member involved in the project (not the PI) leaves UW-Madison, they may (with approval of the PI) take (only) copies of research data they have generated or which they have made substantial contributions to with them. If the study is going to remain open at UW after the study team member leaves, but that study team member will continue to collaborate on the study at UW, you are strongly encouraged to consult with the HRPP Reliance and Navigation Team (RELIANT) on campus ( However, regardless of who is taking research data with them, there are additional non-IRB processes that will also need to be addressed. Please see sections below.


When the PI leaves and wants to take the original research data or specimens, or when a study team member leaves and wants to take copies of the research data or specimens, there are contractual agreements that may be needed in order to share individual level human subjects research data/specimens.  These agreements include but are not limited to: Data Transfer and Use Agreements (DTUA), Clinical Trials Agreements (CTA), Material Transfer Agreements (MTA), Consortium Agreements, or Sponsored Research Agreements.  These agreements establish terms and conditions to protect the interests of researchers and the institution, and importantly - to protect the confidentiality of the human subjects involved. Such agreements cover a variety of important issues, including restrictions on permitted uses and further disclosures of data, authorship, attribution, warranties, confidentiality, liability, and intellectual property. The specific type of agreement needed varies based on the nature of the data/specimens and research study.

For more information on sharing data outside UW-Madison or transferring data to UW-Madison from another institution, please see the HRPP’s guidance on External Sharing and Receiving of human subjects research data.

Data Retention

Additionally, per UW-Madison campus policy, research data must be retained using campus resources for at least 7 years following the conclusion of the study, and as noted above, the original data must be retained at UW–Madison by the PI. It is considered the PI’s responsibility to either retain or make provisions for retaining the research data from the study or studies they are overseeing. Records will normally be retained in the unit where they are produced, but other campus resources are also available (see Data Storage Finder Tool for more options).  For questions about campus data retention policies, please contact Associate Vice Chancellor for Research Policy and Integrity, Brian Fox at or (608) 262-1044.


Previous editions of the HRPP Newsletter can be found here.